Mass Spectrometry Analysis is performed on state-of-the-art instrumentation to achieve trustworthy drug discovery and development data. Mass Spectrometric Data Analysis helps provide crucial answers for safety and efficacy to industry and regulators alike by boosting our understanding of PK/TK/BABE parameters and proven biomarkers, etc. NorthEast BioLab has dedicated scientists, technical know-how, and several types of AB-Sciex equipment to perform your high-value Mass Spectrometry Data Analysis promptly.
Mass spectrometry analysis has become an integral part of all phases of drug R&D over the last decade. It has undoubtedly accelerated the intricate, consuming, and intensive drug discovery and development process at each phase and continues to contribute invaluable insight for driving drug innovation in the right direction.Typical mass spectrometry data analysis platform for drug or biomarker testing consists of the following –
Here, the analyte is ionized utilizing any of the various technologies. Put differently, Ion source in the mass spectrometer is responsible for applying a charge to the analyte. Consequentially, every analyte that passes through this stage has a specific mass-to-charge ratio.
Next, the mass analyzer assesses the mass-to-charge values for the ions and sorts them on the basis on these values. The fundamental principles of particle physics are harnessed for the analysis – positive ions move in the direction of the negative plates at varying speeds. Heavier the molecules, lower the velocity. Furthermore, the magnetic field is used to deflect the ions at varying velocity depending upon the mass of ions.
Finally, the function of the mass detector is to count the molecules passing through the sensor with different mass-to-charge values and obtain a computerized mass spectrum.
The entire system is controlled by software that enables operating all units together, as well as acquiring and interpreting data for the final output, i.e., report on quantitative analysis of the drug.
Our projects with NorthEast BioLab include method development, stability studies, cross-validation of other labs, support for investigator-sponsored studies, and Clinical Phase I – IV studies. They have considerably exceeded our expectations time and again.
NorthEast BioLab provided critical insight into data analysis, and are compliant with industry best practices and regulatory standards. We would certainly recommend them and look forward to working together in the future.
NorthEast Biolab truly goes that extra mile to make the collaboration successful, and I will continue to enjoy very productive interactions with them in the future. The integrity of the staff is as refreshing as their willingness to provide ingenious scientific input and high-quality data.
Our latest study together was a pivotal bioequivalence study, where samples from a cross-over study with about 100 volunteers needed swift analysis. This study, same as all other bioanalytical studies with NorthEast BioLab, was completed with very high quality and reporting standard and incredible responsiveness.
NorthEast Biolab is by far the most responsive and thorough bioanalysis service provider. They work closely with the client to provide the most efficient and cost-effective approach to get the job done.
We have worked with NorthEast Biolab on several programs and have found them to be professional, collaborative, and responsive. As a small company, our vendors are key members of our project teams. The scientists at NorthEast Biolab are technical experts, who produce high-quality data, on-time, and on-budget.
By itself, the mass spectrometry analysis is a highly sensitive detector that becomes even more powerful when coupled with other front-end technologies, such liquid chromatography (LC), gas chromatography (GC), supercritical fluid chromatography (SFC), capillary electrophoresis (CE), inductively coupled plasma (ICP), etc. These days mass spectrometer coupled with liquid chromatography provides a tool not only for pharmacokinetic studies studies but also proteomics, metabolomics, and genomics research.
For small molecules analysis in biological fluids, Multiple Reaction Monitoring is used to obtain highly selective detection. In multiple reactions monitoring (MRM), a parent ion is monitored in Q1 and its unique fragment ion in Q3. In some cases, it may even be necessary to modify the analyte chemically for improving the mass spectrometry analysis assay. This technique is known as chemical derivatization and is used for enhancing the selectivity and sensitivity of the analyte in mass spectrometry analysis.
Bioanalysis is an essential tool in drug discovery and development for determining the concentration of drugs and their metabolites as well as various pharmacodynamics biomarkers in biological fluids. In these analyses, scientists use developed an….
Mass spectrometry analysis plays a critical role in drug discovery chemistry when thousands of compounds are tested to select the compound with the highest probability of success in becoming a drug candidate for development.
Once drug candidates with good bioavailability are selected, additional dose range finding (DRF) studies are performed in various animal species to enable IND filing. These Tox studies require full toxicokinetic analysis for exact measurement of the drug in rodent and non-rodent species. Mass spectrometry analysis coupled with Liquid chromatography can be used for the analysis of drugs from these studies.
Once the drug moves into the clinical phase, mass spectrometry analysis further helps with pharmacokinetic studies related to NDA filing.
NorthEast BioLab has outstanding capabilities for mass spectrometry analysis. Our scientists have 15+ year experience in developing and validating hundreds of LC-MS/MS methods in various biological matrices. Although mass spectrometry data analysis has become routine, laboratory staff continue to face several challenges given the continually evolving nature of the science and application in sophisticated assays. Our veteran team is adept at optimizing mass spectrometer conditions and developing robust and sensitive methods on the platform. We can guide you all the way from assay development, lead optimization, preclinical testing to clinical trials.
We offer mass spectrometry analysis based method development, transfer, validation, and sample analysis for quantitative evaluation of small molecules. Our scientists comply with Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) for conducting preclinical rodent, non-rodent, and clinical studies on healthy volunteers and patients respectively. Ultimately, our expertise along with operational excellence always allows us to maintain regulatory compliance.
NorthEast BioLab adopts various client-centric approaches and collaboration techniques to accelerate your drug program. For example, structural, experimental, and functional changes are quickly forwarded with sponsor approval to avoid delays and related expenses. Furthermore, our lab scientists and analysts always remain fully transparent as our strategic partnership with clients is based out foundational values.
